The main objective of the present study is to verify whether respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles with load adjustment based on the principles of the 1-repetition maximum (RM) test), applied by telerehabilitation, is an effective intervention (versus a respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles with convetional load adjustment) in improving fragility, quality of life and physical function in people with Multiple Sclerosis.
It is a single-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Inspiratory muscle training + Expiratory muscle training with load adjustment based on the principles of the 1-repetition maximum (RM) test , 2) Inspiratory muscle training + Expiratory muscle training with convetional load adjustment. Each exercise training program will be applied twice (morning inspiratory muscle training session and evening expiratory muscle training session) per day 5 sessions per week during 8 weeks by a threshold device. The sessions will be supervised by a physiotherapist through a virtual platform. Participants received baseline assessments at the beginning of the intervention, at the end of the 4th week (only the group 2), and post-intervention assessments at the end of the 8th week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Participants will engage in respiratory muscle training programme at home using a respiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided by telerehabilitation. The load adjustment will be based on the principles of the 1-repetition maximum (RM) test.
Participants will perform an inspiratory and expiratory muscle training program by a threshold device at home, twice a day (morning inspiratory muscle training session and evening expiratory muscle training session) for 8 weeks supervised by a physiotherapist through a virtual platform. The load adjustment will be based on the conventional test to be performed during the 4th week.
Asociación Mostoleña de Esclerosis Múltiple
Móstoles, Madrid, Spain
Respiratory muscle strength
Maximal inspiratory preassure and Maximal expiratory preassure
Time frame: Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Inspiratory muscle endurance
Inspiratory muscle endurance will be assed by an incremental load test that required subjects to breathe against inspiratory threshold loads that were increased each minute by 10% of baseline PI,max until voluntary task failure muscle endurance test. Inspiratory muscle endurance was defined as the PI,max sustained for a minimum of 1 min.
Time frame: Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Health related quality of life
To evaluate the health-related quality of life of the participants a valid, reliable and generic questionnaire will be used. EuroQol-five-dimensional Questionnaire a numerical value represented Health state as EQ-5D 'index values' or 'index scores' reflecting how good or bad a health state is. It consisted of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.
Time frame: Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Fatigue
Modified Fatigue Impact Scale (MFIS). The MFIS is a valid and reliable instrument for assessing fatigue severity. It consists in 21 items. Higher scores mean a worse fatigue.
Time frame: Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Fragility
Frailty indexes (FI) and the Comprehensive GeriatricAssessment (CGA) are multidimensional tools. FI serve to quantitatively measure frailty levels. They have shown to have an excellent correlation with mortality.
Time frame: Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Degree of disability
The Barthel index (BI) is a 10-item activities of daily living ordinal scale used primarily for disability measurement. The values assigned to each item are based on the time and amount of physical assistance required for a patient to perform a common daily activity.
Time frame: Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Ibai López de Uralde Villanueva Ibai López de Uralde Villanueva, PhD, PhD
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